DarshanTalks Podcast

 

 

Operational Engagement With Patient Advocates

January 21, 2020

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Darshan: Hello everyone. Welcome to another episode of Darshan Talks. We have Trishna Bharadia with us again and I'm really excited because we had a whole conversation pretty recently around the practical considerations of being a patient advocate, and how people want to engage with patient advocates, what make it really difficult.

Darshan: But one of the things Trishna mentioned in the last conversation is the problems around informed consent and how they've gotten ridiculous to be quite honest. And a part of me as a lawyer believes that, that's completely legitimate because we're trying to protect the company.

Darshan: But then there's the practical element of this. So Trishna, if you could introduce yourself and then sort of go off on what are some of the issues with informed consent and what might be some solutions if you will.

Intro: This is the Darshan Talks podcast, regulatory guy, irregular podcast with host, Darshan Kulkarni. You can find the show on twitter @DarshanTalks or the show's website at darshantalks.com.

Trishna: My name is Trishna Bharadia, I'm from the UK and I'm a health advocate and patient engagement champion. So I work to get the patient voice heard louder, stronger and more effectively within the entire healthcare journey. And so in terms of particularly informed consent and patient information, leaflets when it comes to participating in clinical trials and research studies.

Trishna: So for me it's very much... I mean to be honest, they're too long, they're too complex, the language that is used is far too complicated. And I take the attitude, yes, we need to have the legal protection, not just thought the sponsor, but for the patient as well.

Trishna: But at the end of the day, if a patient doesn't understand what they're signing and doesn't understand the information being conveyed to them, then that document isn't fit for purpose. So an example I was recently sent two patient information leaflets and informed consent forms for clinical trials that somebody that I know who lives with inflammatory bowel disease, that they had been sent by their doctor because at the moment there is two clinical trials that could potentially be a way forward for their own treatment.

Trishna: And they sent me these documents and say, "Could you have a read of them. I know you're a health advocate and your obviously used to reading these documents and just let me know what you think." Now for each study there was 30 plus pages to read through. The language was not patient friendly at all and the entire document was just, it was very complex.

Trishna: There was a lot of text in there so it looked completely overwhelming. And one of the studies in particular within the study itself, there was multiple branches, there was lots of sub studies going on within this clinical trial. And I came away from reading those two documents, well over 60 pages worth of information and I didn't feel informed.

Trishna: I didn't really understand what the trials were, what was involved in them and what the patient commitment would be. And to be a perfectly honest, they gave me a bit of a headache because languag...

 

Pharmacy Engagement

 

 

 

Pharmacy Engagement

January 16, 2020

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Darshan: Hey everyone, welcome to another episode of Darshan Talks. We have a special guests with us. She's joined us before and she has been extremely well received. We have Trishna and Trishna I'm going to let you reintroduce yourself.

Trishna: Oh, okay. So yeah, my name is Trishna Bharadia And I'm a patient advocate and a patient engagement champion. So I basically I work to get the patient voice heard louder, stronger, more effectively throughout the entire healthcare journey.

Trishna: Whether that's through collaboration with industry, through collaboration with clinicians, patient organizations, individuals who are living with chronic illness or serious diseases. And it's about basically getting all the stakeholders together, working in a collaborative way to make sure that the patient voice is being heard better.

Intro: This is the Darshan Talks podcast, regulatory guy, irregular podcast with host Darshan Kulkarni. You can find the show on Twitter @DarshanTalks or the shows website at darshantalks.com.

Darshan: Which really raises the important question of if you want to get the patient's voice heard better, you want to make sure that patients are in the room. And one of the big conversations that we've had is how has become more and more important over time to ensure that the patients are in the room.

Darshan: But Trishna you and I have had this conversation before and I know we've had conversations with other people, what patients are feeling like you're giving me the... You're telling me that you want to hear my voice, but you're making it difficult for me to appear and show up and sort of give my voice.

Darshan: So what I'd like to do today for today's talk, is talk a little bit about how PhRMA and the life sciences industry and health in general, maybe needs to better work with patients to enable them to be able to give and position their voice. Does that question make sense? Does that scenario make sense?

Trishna: Yes. No, definitely because it's actually something which I don't think at the moment industry is getting completely right. There might be a willingness to engage with patients, but in order to do that effectively and to be able to engage patients and what I would say an appropriate manner, I think there is a long way to go and a lot of it is to do with basically being considerate to patient needs to patient requirements.

Trishna: I often say when I'm working with industry, I often say to people, ask me what will make it easier and what will facilitate me to be able to participate in this particular project? Because, so this is the other thing, there's no blanket one size fits all when it comes to patient engagement.

Trishna: Every single patient, whether they have a specific disease or whether it's patients within a specific disease area, they all have different requirements and being able to meet those requirements will enable patients to more effectively give their input.

Trishna: So, I think industry in general needs to look at the way that they're engaging with patients and make sure it's more appropriate to each individual depending on obviously exactly what they're asking them to do.

Darshan: So obviously that sounds great in general but are there some specifics that you would say advocates more than others, if you will?

Trishna: Yeah,

Darshan: Hey, everyone. Welcome to another episode of Darshan Talks. We have a very, very special guest for you. We've got Dale Cook and Dale Cook is the guy you talk to when it comes to promotional compliance. I do a bunch of work in it. He does a bunch of work in it. We talk a lot about this. He's the guy I've always reached out to and we have a camaraderie going. So I have this great opportunity for us to talk and learn more from him.

Intro This is the DarshanTalks Podcast, Regulatory Guy, Irregular Podcast with host Darshan Kulkarni. You can find the show on Twitter @darshantalks or the show's website @darshantalks.com.

Darshan: Dale, do you want to introduce yourself a little bit?

Dale: Sure. Thanks, Darshan for having me on. I've been following your podcast since you launched it. I'm really glad that we were able to work out some time to have this discussion, and I appreciate you opening up your audience.

Dale: I am an FDA regulatory consultant. I started my independent practice five years ago. The tagline I use associated with my company is I help companies use 21st century technologies while communicating about FDA regulated products. And remaining compliant with regulations written in the 1960s. That core challenge of the Regs themselves have not changed and there are good aspects of that, right? We don't want the Regs constantly changing, but the world in which we live is very, very different from the world in which those Regs were written. And that is that mismatch between the world for which they were written and the world in which we actually wake up every day, I think presents one of the challenges for the companies that you and I both advise.

Darshan: So that really brings us to the first question of, Regs changing and one of the areas that Regs are, well, not the Regs but the laws are changing, is in the area of compliance and in the area of off-label compliance specifically. Before we go down that path, the real question is what does, well, let's start with what is on-label, first of all? What does the word label mean? How is that different from labeling and why does any of this matter?

Dale: Right. Yeah, so I mean the major significant radical change in the law in the 1960s going back to the Kefauver Harris hearings, was this notion that companies had to demonstrate that products were safe and effective prior to bringing the product to market as a new drug. And so if you create, invent, discover a new drug, you have to demonstrate to the FDA prior to introducing it to market that it's effective. The minute you do that, the minute you introduce that concept, you have to get the for what, right? Effective for what?

Dale: And that introduces the idea of an indication. So your product doesn't get introduced to the market tout court, it's on the market you can do whatever you want with it. You may only introduce it into the marketplace for those specific indications where you have demonstrated to the FDA that the product is safe and effective.

Dale: So that's the concept of an on-label use. An on-label use of a product is any use of the product where the company has, in fact, demonstrated that it is safe and effective and they have the labeling approved by the FDA for such use.

Dale: And then off-label use is anything else, right? Anything else, meaning in a different patient population. The vast majority of drugs come on the market only indicated for use in adults, but of course children get ill too. So pediatricians are constantly faced with the challenge of using new products when they're using them probably in an off-label manner.

 

 

Off-Label Promotion Is Not Going Away

December 26, 2019

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[learn_more caption="Read Transcript" align="right"]

Darshan: Hello everyone. Welcome to another episode of Darshan Talks. We have Dale Cook with us, and Dale as many of you may know, is one of the experts when it comes to promotional compliance. And he's joined us today. We're going to be talking about off-label communications, off-label promotion, and why does the world think that off-label promotion is here to stay?

Speaker 3: This is the DarshanTalks podcast, regulatory guy, irregular podcast with host Darshan Kulkarni. You can find the show on Twitter @darshantalks, or the show's website at darshantalks.com.

Dale: Thanks so much Darshan. Yeah, why is off-label promotion here to stay? Well, I mean as a concern for pharmaceutical companies, it's never going to go away as long as the existing NDA system is in place, right? Because as we talked about in a previous podcast, the whole notion of bringing a product to market requires that the FDA evaluate a limited set of information for specific indications and specific uses.

Dale: And the FDA as recently as two days before the Obama administration ended, they published that memorandum on First Amendment and off-label concerns. I don't want to parody or otherwise give short trips to a 63-page document, but I think it's fair to say that a one-sentence summation could be "We're right and y'all are wrong." Off-label promotion is a bad thing and we're right about that and everybody else who has come up with any other idea is just wrong and we are not going to back down.

Dale: At its core, the whole idea of off-label promotion potentially decimates the entire structure of the NDA system. I mean what would it be like if the FDA knew that when it was evaluating and reviewing a product prior to coming to market, if the FDA knew that you could then go out and market that product for absolutely anything without ever having to conduct any additional scientific research, what would you do? I mean what would the incentive structure be in that situation? The incentive structure would be bring the product to market with the absolute easiest possible thing to demonstrate.

Dale: The product will eliminate a headache, or will reduce nausea or whatever that easiest possible thing to demonstrate is, and then promote the product for whatever the most expensive, greatest demand is. You bring the product to market showing that it reduces nausea and then you promote it as a cure for cancer. Or you promote it as the way to prevent birth defects, or the way to extend your life forever. And you just have no obligation to actually demonstrate that it works and the FDA would know that.

Dale: So then the incentive structure on the FDA side becomes to not let the products on the market. Because they would be terrified that you're bringing it to market having demonstrated X, but they know that X is not really what you're going to promote it for. So then their incentive would be to make the review and approval process as difficult as possible to bring the products to market. So that world where off-label promotion is no longer viewed at all as being anything bad or at all being at all prohibited is from my perspective, terrifying. Because I don't understand how the entire NDA process works anymore.

Darshan: So I'm going to challenge you on that Dale....

 

 

Is Off Label Promotion Going Away?

December 24, 2019

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[learn_more caption="Read Transcript" align="right"]

Darshan: Hey, everyone. Welcome to another episode of Darshan Talks. We have a very, very special guest for you. We've got Dale Cook and Dale Cook is the guy you talk to when it comes to promotional compliance. I do a bunch of work in it. He does a bunch of work in it. We talk a lot about this. He's the guy I've always reached out to and we have a camaraderie going. So I have this great opportunity for us to talk and learn more from him.

Intro This is the DarshanTalks Podcast, Regulatory Guy, Irregular Podcast with host Darshan Kulkarni. You can find the show on Twitter @darshantalks or the show's website @darshantalks.com.

Darshan: Dale, do you want to introduce yourself a little bit?

Dale: Sure. Thanks, Darshan for having me on. I've been following your podcast since you launched it. I'm really glad that we were able to work out some time to have this discussion, and I appreciate you opening up your audience.

Dale: I am an FDA regulatory consultant. I started my independent practice five years ago. The tagline I use associated with my company is I help companies use 21st century technologies while communicating about FDA regulated products. And remaining compliant with regulations written in the 1960s. That core challenge of the Regs themselves have not changed and there are good aspects of that, right? We don't want the Regs constantly changing, but the world in which we live is very, very different from the world in which those Regs were written. And that is that mismatch between the world for which they were written and the world in which we actually wake up every day, I think presents one of the challenges for the companies that you and I both advise.

Darshan: So that really brings us to the first question of, Regs changing and one of the areas that Regs are, well, not the Regs but the laws are changing, is in the area of compliance and in the area of off-label compliance specifically. Before we go down that path, the real question is what does, well, let's start with what is on-label, first of all? What does the word label mean? How is that different from labeling and why does any of this matter?

Dale: Right. Yeah, so I mean the major significant radical change in the law in the 1960s going back to the Kefauver Harris hearings, was this notion that companies had to demonstrate that products were safe and effective prior to bringing the product to market as a new drug. And so if you create, invent, discover a new drug, you have to demonstrate to the FDA prior to introducing it to market that it's effective. The minute you do that, the minute you introduce that concept, you have to get the for what, right? Effective for what?

Dale: And that introduces the idea of an indication. So your product doesn't get introduced to the market tout court, it's on the market you can do whatever you want with it. You may only introduce it into the marketplace for those specific indications where you have demonstrated to the FDA that the product is safe and effective.

Dale: So that's the concept of an on-label use. An on-label use of a product is any use of the product where the company has, in fact, demonstrated that it is safe and effective and they have the labeling approved by the FDA for such use.

Can Health Literacy Boost Transparency in the Life Sciences?

Transparency is highly beneficial in the life sciences—leading to more engagement among patients and lower dropout rates for clinical trials. The American College of Physicians defines transparency as the act of making available to the public information on the health care system’s quality, efficiency, and consumer experience with care. To encourage this kind of transparency, life science companies should focus on ensuring that their patients have access to understandable health resources and clinical trials, and also foster an environment in which their employees engage in health literate practices.

Making Clinical Trials Understandable to Subjects

One way that life science companies can promote health literacy is by structuring their clinical trials so that patients can easily navigate them. This means that companies must first examine their health resources and clinical trials to ensure that patients can understand them. If certain materials prove too dense, companies should focus on re-working them so they are more comprehensible to their patients. Adapting health materials and resources will develop a clinical trial that patients can be truly engaged with and understand. By creating more health literate clinical trials, companies will probably experience a decrease in their patient dropout rate and higher rates of participation among subjects. Overall, the value of strengthening health literacy in clinical trials is worth the effort for companies, particularly if it means keeping study subjects and increasing engagement levels. 

How Should Companies Encourage Health Literacy in Employees?

Health literacy is not strictly the domain of patients—it also enables employees to navigate the health care system more easily. To encourage health literacy skills among employees, businesses should work on integrating health literate practices into their core structure. Health literate practices can include anything from sharing written medical information to providing detailed explanations of health benefits to employees. By developing the health literacy of their employees, companies can indirectly create an environment that encourages health literacy and accessibility among customers. If employees are health literate, they will probably develop trials that implement health literate practices, making them more accessible for patients.

Conclusion

Although transparency is an ongoing concern in the life science industry, companies can address this problem by ensuring that their resources promote health literacy. Companies should consult with a legal expert to ensure that their health resources are fully accessible for patients.

If you have any other questions about how to communicate with the FDA or how your past and/or current FDA communications affect you and your business goals, reach out to me on Twitter, LinkedIn, or send me a message here.

I also host a podcast called DarshanTalks, a show that discusses newsworthy FDA issues and how they apply to bringing a product to market – and keeping it there. From patient centricity in clinical trials to the government shutdo...